3
CHAPTER 1:
Healthcare Landscape and Drug Development
agency works effectively with partnering organizations.12
EMA on the Global Regulatory Stage
Like FDA, EMA acknowledges the importance and requirement
for international collaboration. It believes this will also ensure data
integrity to support clinical trials and manufacturing, encourages
a global approach to authorization and supervision of medicines,
and avoid unnecessary duplication of efforts. Such a collaboration
aims to create efficiencies by promoting the effective use of global
regulatory resources.13 Confidentiality arrangements or mutual
recognition agreements (MRAs) are critical for such bilateral
activities and heavily used by EMA and European Commission to
work closely in all international activities. Confidentiality arrange-
ments facilitate the exchange of confidential information between
regulators. MRAs on good manufacturing practice (GMP) allow
EU authorities to rely on GMP inspections performed by other
regulators, waive batch testing of products on entry into the EU
and share information on inspection-related information and
quality defects.14
The EU has MRAs with various countries, including Austra-
lia, Brazil, Canada, Israel, Japan, New Zealand, Switzerland, and
the US. EMA also supports European Commission collaborations
with Russia, India, and China through specific EU frameworks.15
EMA also works with the International Council for Har-
monisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH), the International Coalition of Medicines
Regulatory Authorities (ICMRA), the International Pharmaceu-
tical Regulators Forum (IPRF), WHO, the Council of Europe,
the Organisation for Economic Co-operation and Development
(OECD), Codex Alimentarius, the Office International des Epi-
zooties (OIE), and the European Free Trade Association (EFTA).
Additionally, EMA is involved in multiple initiatives, such as:
• EU-US Mutual Reliance Initiative on GMP inspection
• Increasing collaboration with China and India
• Reform of ICH governance and science
• Common FDA-EMA application form and annual report for
orphan designation
• International Generic Medicines Assessment pilot and
• International cooperation on approaches to Ebola treatment
and prevention16
International Council for Harmonisation
ICH was founded in 1990 to build harmonization between
regulators and the pharmaceutical industry. It was reformed into
a non-profit legal entity under Swiss law in October 2015. Its
mission includes promoting public health contributing to the
development, manufacturing, registration, and supervision of new
medicines and developing technical guidelines that can be imple-
mented by the regulatory authorities. ICH17 has grown in terms of
its global membership, including members, observers, and experts.
More recently, even the generic and over-the-counter industries
have joined ICH. The ICH organization includes 20 members and
36 observers spread across various regulatory agencies, including
the US FDA, EC, Pharmaceuticals and Medical Devices Agency
(Japan), Swissmedic (Switzerland), etc., and industry members
like EFPIA (European Federation of Pharmaceutical Industries
and Association) and PhRMA (Pharmaceutical Research and
Manufacturers of America.18 It also has numerous working groups
with many experts working towards the process of harmonization
and creation and implementation of ICH guidelines. The process
of harmonization and development of guidelines is a multi-step
process requiring consensus between regulators on the guideline
topic and content to its adoption and implementation in various
ICH regions.19 As of March 2023, over 70 ICH guidelines have
been drafted on technical requirements around Safety, Quality,
Efficacy, and Multidisciplinary. Some of the major advantages/
successes of ICH include:
• Common Technical Document (CTD) and electronic CTD
(eCTD), which brings together all Quality, Safety, and Effi-
cacy information in a common, harmonized format accepted
by regulators in all ICH regions.20
• Clinical trials conducted in one ICH region can be used
in other ICH regions by setting the common standards on
science and ethics.
• Medical Dictionary for Regulatory Activities (MedDRA) is
a highly specific, standardized medical terminology used to
facilitate sharing of regulatory information used for regis-
tration, documentation, and safety monitoring of medical
products before and after marketing authorization.21
Conclusion
There is an ongoing evolution in the regulatory landscape as health
authorities worldwide acknowledge the globalization of drug de-
velopment processes and are working towards supporting the safe,
efficacious, and cost-effective development of such products. FDA
and EMA regulations and ICH guidelines continue to evolve
to reflect the complexity of regulated products and fulfill public
health goals. They play a key role in ensuring quality management
and bias- and corruption-free approval and use of these drugs,
whether being imported or exported to their specific regions.
References
All references accessed 4 March 2023.
1. International Council for Harmonisation. Mission. https://www.ich.
org/page/mission
2. Food and Drug Administration. What We Do. Current as of 28
March 2018. https://www.fda.gov/about-fda/what-we-do
3. Food and Drug Administration. FDA globalization. Current as of 21
December 2022. https://www.fda.gov/international-programs/fda-
globalization
4. Food and Drug Administration. Inspections, compliance, enforcement,
and criminal investigation. https://www.fda.gov/inspections-
compliance-enforcement-and-criminal-investigations
5. Food and Drug Administration. Import program – Food and Drug
Administration (FDA). Current as of 15 July 2022. https://www.fda.
gov/industry/import-program-food-and-drug-administration-fda
6. Food and Drug Administration. Office of Compliance and Biologics
Quality (OCBQ). Current as of 10 October 2018. https://www.
fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-
CHAPTER 1:
Healthcare Landscape and Drug Development
agency works effectively with partnering organizations.12
EMA on the Global Regulatory Stage
Like FDA, EMA acknowledges the importance and requirement
for international collaboration. It believes this will also ensure data
integrity to support clinical trials and manufacturing, encourages
a global approach to authorization and supervision of medicines,
and avoid unnecessary duplication of efforts. Such a collaboration
aims to create efficiencies by promoting the effective use of global
regulatory resources.13 Confidentiality arrangements or mutual
recognition agreements (MRAs) are critical for such bilateral
activities and heavily used by EMA and European Commission to
work closely in all international activities. Confidentiality arrange-
ments facilitate the exchange of confidential information between
regulators. MRAs on good manufacturing practice (GMP) allow
EU authorities to rely on GMP inspections performed by other
regulators, waive batch testing of products on entry into the EU
and share information on inspection-related information and
quality defects.14
The EU has MRAs with various countries, including Austra-
lia, Brazil, Canada, Israel, Japan, New Zealand, Switzerland, and
the US. EMA also supports European Commission collaborations
with Russia, India, and China through specific EU frameworks.15
EMA also works with the International Council for Har-
monisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH), the International Coalition of Medicines
Regulatory Authorities (ICMRA), the International Pharmaceu-
tical Regulators Forum (IPRF), WHO, the Council of Europe,
the Organisation for Economic Co-operation and Development
(OECD), Codex Alimentarius, the Office International des Epi-
zooties (OIE), and the European Free Trade Association (EFTA).
Additionally, EMA is involved in multiple initiatives, such as:
• EU-US Mutual Reliance Initiative on GMP inspection
• Increasing collaboration with China and India
• Reform of ICH governance and science
• Common FDA-EMA application form and annual report for
orphan designation
• International Generic Medicines Assessment pilot and
• International cooperation on approaches to Ebola treatment
and prevention16
International Council for Harmonisation
ICH was founded in 1990 to build harmonization between
regulators and the pharmaceutical industry. It was reformed into
a non-profit legal entity under Swiss law in October 2015. Its
mission includes promoting public health contributing to the
development, manufacturing, registration, and supervision of new
medicines and developing technical guidelines that can be imple-
mented by the regulatory authorities. ICH17 has grown in terms of
its global membership, including members, observers, and experts.
More recently, even the generic and over-the-counter industries
have joined ICH. The ICH organization includes 20 members and
36 observers spread across various regulatory agencies, including
the US FDA, EC, Pharmaceuticals and Medical Devices Agency
(Japan), Swissmedic (Switzerland), etc., and industry members
like EFPIA (European Federation of Pharmaceutical Industries
and Association) and PhRMA (Pharmaceutical Research and
Manufacturers of America.18 It also has numerous working groups
with many experts working towards the process of harmonization
and creation and implementation of ICH guidelines. The process
of harmonization and development of guidelines is a multi-step
process requiring consensus between regulators on the guideline
topic and content to its adoption and implementation in various
ICH regions.19 As of March 2023, over 70 ICH guidelines have
been drafted on technical requirements around Safety, Quality,
Efficacy, and Multidisciplinary. Some of the major advantages/
successes of ICH include:
• Common Technical Document (CTD) and electronic CTD
(eCTD), which brings together all Quality, Safety, and Effi-
cacy information in a common, harmonized format accepted
by regulators in all ICH regions.20
• Clinical trials conducted in one ICH region can be used
in other ICH regions by setting the common standards on
science and ethics.
• Medical Dictionary for Regulatory Activities (MedDRA) is
a highly specific, standardized medical terminology used to
facilitate sharing of regulatory information used for regis-
tration, documentation, and safety monitoring of medical
products before and after marketing authorization.21
Conclusion
There is an ongoing evolution in the regulatory landscape as health
authorities worldwide acknowledge the globalization of drug de-
velopment processes and are working towards supporting the safe,
efficacious, and cost-effective development of such products. FDA
and EMA regulations and ICH guidelines continue to evolve
to reflect the complexity of regulated products and fulfill public
health goals. They play a key role in ensuring quality management
and bias- and corruption-free approval and use of these drugs,
whether being imported or exported to their specific regions.
References
All references accessed 4 March 2023.
1. International Council for Harmonisation. Mission. https://www.ich.
org/page/mission
2. Food and Drug Administration. What We Do. Current as of 28
March 2018. https://www.fda.gov/about-fda/what-we-do
3. Food and Drug Administration. FDA globalization. Current as of 21
December 2022. https://www.fda.gov/international-programs/fda-
globalization
4. Food and Drug Administration. Inspections, compliance, enforcement,
and criminal investigation. https://www.fda.gov/inspections-
compliance-enforcement-and-criminal-investigations
5. Food and Drug Administration. Import program – Food and Drug
Administration (FDA). Current as of 15 July 2022. https://www.fda.
gov/industry/import-program-food-and-drug-administration-fda
6. Food and Drug Administration. Office of Compliance and Biologics
Quality (OCBQ). Current as of 10 October 2018. https://www.
fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-